BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3116744 · Received May 16, 2013

    Report

    Report Number
    1723170-2013-00350
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAD PERFORMED A TOUCH N GO REGISTRATION AND THE SURGEON DID NOT NOTICE THAT THE REGISTRATION FLIPPED LEFT/RIGHT DURING ACCURACY CHECK. AFTER HE MADE THE CUT AND WAS AT THE DURA HE NOTICED IT WAS INACCURATE. THE REP WAS TROUBLESHOOTING WITH THE NEURO-COORDINATOR OVER THE PHONE AND HAD HIM REACH UNDER THE DRAPE AND PERFORM A TRACER REGISTRATION WHICH PASSED AND RESOLVED THE ISSUE. TO PREVENT THE TOUCH N GO REGISTRATIONS FROM FLIPPING LEFT/RIGHT THE REP HAS TAUGHT THE SITE HOW TO PUT ON FIDUCIAL MARKERS IN A WAY THAT WILL NOT CAUSE THE ORIENTATION TO FLIP. HOWEVER, FOR THIS CASE THE SITE FAILED TO FOLLOW THE DIRECTIONS. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAS PERSISTED IN USING SYMMETRICAL FIDUCIAL MARKER PLACEMENT FOR TOUCH N GO REGISTRATION DESPITE MULTIPLE ATTEMPTS TO TRAIN THEM OTHERWISE. THE REP REITERATED THE IMPORTANCE OF NOT PLACING FIDUCIAL MARKERS IN A WAY THAT IS SYMMETRICAL IN ORDER TO PREVENT THIS ISSUE IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER. THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE ROOT CAUSE WITHOUT FURTHER INFORMATION. NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE SURGEON ALLEGED AN INACCURACY OF NONSPECIFIC AMOUNT. THE SURGEON REGISTERED THE PATIENT, CHECKED ACCURACY AND DEEMED EVERYTHING TO BE ACCURATE. AFTER REACHING THE PATIENT'S DURA, THE SURGEON FELT INACCURATE. THE SITE RE-DRAPED, RE-REGISTERED THE PATIENT (POST-INCISION) AND CHECKED ACCURACY. AFTER CONFIRMING ACCURACY, THE SURGEON CONTINUED THE USE OF THE NAVIGATION SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217379 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR